ph3Work Schedule /h3pStandard (Mon-Fri) /ph3Environmental Conditions /h3pOffice /ph3Job Description /h3pJoin Us as a FSP Clinical Research Associate (Level II) – Make an Impact at the Forefront of Innovation /ppWe have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. /ppAs part of our global team, you’ll have the opportunity to perform and coordinate all aspects of the clinical monitoring and site management process. As a Clinical Research Associate (Level II), you'll conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. You will manage procedures and guidelines from different sponsors. Acting as a site processes specialist, you will ensure that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects' rights, well-being, and data reliability. You will ensure audit readiness and develop collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to your role are outlined in the task matrix. /ph3What You’ll Do: /h3ulliMonitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process.



Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable. /liliParticipates in investigator meetings as necessary. /liliIdentifies potential Investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials. /liliEnsures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications. /liliProvides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System). /liliFacilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts. /liliResponds to company, client and applicable regulatory requirements/audits/inspections. /liliMaintains completes administrative tasks such as expense reports and timesheets in a timely manner. /liliContributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members. /liliContributes to other project work and initiatives for process improvement, as required. /li /ulh3Education and Experience Requirements: /h3ulliBachelor's degree in a life science related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification. /liliPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years as a clinical research monitor). /liliValid driver's license. /li /ulpIn some cases, an equivalency,



consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. /ph3Knowledge, Skills and Abilities: /h3ulliProven clinical monitoring skills /liliDemonstrated understanding of medical/therapeutic area knowledge and medical terminology /liliDemonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents /liliWell-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving /liliAbility to manage Risk Based Monitoring concepts and processes /liliGood oral and written communication skills, with the ability to communicate effectively with medical personnel /liliAbility to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issues /liliGood organizational and time management skills /liliEffective interpersonal skills /liliAttention to detail /liliAbility to remain flexibile and adaptable in a wide range of scenarios /liliAbility to work in a team or independently as required /liliGood computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software /liliGood English language and grammar skills /liliGood presentation skills /li /ulh3Working Conditions and Environment: /h3ulliWork is performed in an office and/or home office environment with exposure to electrical office equipment. /liliFrequent drives to site locations. Frequent travel, generally 60-80% but more for some individuals. May also include extended overnight stays. /liliExposure to biological fluids with potential exposure to infectious organisms. /liliPersonal protective equipment required such as protective eyewear, garments and gloves. /liliExposure to fluctuating and/or extreme temperatures on rare occasions /li /ulpThermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. /p /p #J-18808-Ljbffr

📌 FSP Clinical Research Associate II (Roma)
🏢 Thermofisher Scientific
📍 Roma